Label: HEARTBURN RELIEF- aluminum hydroxide and magnesium carbonate suspension

  • NDC Code(s): 57896-565-12
  • Packager: GERI-CARE PHARMACEUTICALS, CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 254 mg
    Magnesium carbonate 237.5 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • laxative effect may occur
    • do not use maximum dosage for more than 2 weeks
    • do not take more than 16 teaspoonfuls in 24 hours

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.In case of overdose, get medical help or
    contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • shake well before use
    • adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor
    • children under 12 years: consult a doctor
    • take after meals and at bedtime
    • dispense product only by spoon or other measuring device
  • Other information

    • each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg
    • store at room temperature
    • protect from freezing
    • keep tightly closed
    • TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is broken or missing.
  • Inactive ingredients

    benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum

  • Questions or comments?

    1-800-540-3765

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF 
    aluminum hydroxide and magnesium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-565
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE254 mg  in 5 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE237.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-565-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00107/01/2024
    Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(57896-565)
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